Company News Feature

DJO Global’s Match Point Used in Two Cases

Elizabeth Hofheinz, M.P.H., M.Ed. • Wed, November 6th, 2013

DJO Global, Inc. has just announced the first surgical uses of its Match Point System patient-specific shoulder instrumentation in Reverse Shoulder System cases in Sydney, Australia, and in Fort Lauderdale, Florida. The Match Point System is CE Marked and has also received FDA 510k clearance.

In collaboration with Materialise, a company focused on patient-specific instrumentation and innovative software solutions, the Match Point System was developed to provide advanced pre-operative surgical planning and patient-customized drill guides to accommodate a reverse or total shoulder arthroplasty procedure. The Match Point System employs Materialise’s proven SurgiCase Connect software to create CT-based pre-operative case plans for surgeons to template and prepare for their reverse shoulder arthroplasty surgeries using the DJO Surgical Reverse or Turon Shoulder Systems. Upon review and plan approval, the surgeon is provided with an ergonomically-designed drill guide that is customized to the patient’s unique glenoid anatomy, enabling greater accuracy in implant positioning.

“With the increased patient demand for total and reverse shoulder replacements, surgeons are demanding more in terms of improved instrumentation, planning tools, and techniques for their shoulder cases, ” said Bryan Monroe, Senior Vice President and General Manager of DJO Surgical, in the October 31, 2013 news release. “The Match Point System is well-suited to address these needs. Our strategic partnership with Materialise has been great; together, we are helping the surgeon to facilitate each patient’s return to normal activity.”

Dr. Jonathan Levy of Holy Cross Hospital in Fort Lauderdale, Florida, who performed the first Match Point System surgery in the U.S., stated, “I am excited about this technology and its impact on shoulder arthroplasty. It will revolutionize our approach to pre-operative planning and our ability to accurately execute the surgical procedure even in the most challenging of cases.”

Bryan Monroe told OTW, “The Match Point System streamlines the pre-operative planning process through the use of case management software that also provides enhanced visualization of the patient’s unique anatomy. A digitized, 3D scapular model is created, and an algorithm suggests implant positioning for surgeon review. Once the pre-operative plan is approved, a 3D printer creates the patient-specific guide for use in surgery. The surgeon is equipped with a greater sense of preparedness leading up to and during the surgery.”

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Biomet Claims First with Shoulder System

Walter Eisner • Fri, September 6th, 2013

On September 4, 2013, Biomet Orthopedics, LLC, announced the first clinical use in the U.S. of the company's Signature™ Patient-Specific glenoid instrumentation. The company says this is the only device of its type that features a patent-pending dual trajectory, allowing surgeons to elect a reverse or total shoulder procedure intraoperatively.

The instrument's glenoid guides utilize CT data and a proprietary algorithm to match each patient's anatomy and facilitate proper positioning of the glenoid component. The announcement stated the preoperative planning tool "allows surgeons to make any necessary adjustments required for each patient, including component size, inclination, and version, prior to surgery."

Shoulders, Hips and Knees

The system complements Biomet’s Access Instrumentation for its Comprehensive shoulder platform, which features patent-pending, four-step cannulated glenoid instrumentation and is the latest addition to company's portfolio of patient-specific instrumentation technology.

The company's Signature™ knee system has been used in over 80, 000 surgeries since its introduction in 2007. Biomet also recently introduced Signature™ instrumentation for acetabular positioning in total hip replacement.

Product Development Team

John Sperling, M.D., a participant in the product development of the system and an orthopedic surgeon in Rochester, Minnesota, said the system "is a major advance in shoulder arthroplasty. In addition to providing a time-efficient and user-friendly solution to consistently place the glenoid component”, Sperling said the system "provides the surgeon the ability to seamlessly choose between anatomic and reverse shoulder arthroplasty.”

Jason Hurst, M.D. another product development participant, said, “Given the inherent exposure and orientation challenges in total shoulder arthroplasty, this technology is ideally suited for the shoulder.” Hurst is an orthopedic surgeon with Joint Implant Surgeons in New Albany, Ohio. He added that the pre-operative plans were well replicated by the guides and very easy to use. "I believe that this tool provides me with reliable implant positioning.”

Simon Frostick, Professor of Orthopedics and surgeon at the Royal Liverpool University Hospital in Liverpool, U.K., said the combination of the Signature™ guide and the new Comprehensive Access cannulated instruments enables him to "position the glenoid component optimally and to implant the component with ease and speed."

Walter Eisner • Tue, August 27th, 2013

The system enables surgeons to plan the implant size and position, as well as bone preparation, including positioning the screw. It does this by utilizing 3D visualization software. European patients and surgeons have had access to the system since last May.

In an August 23, 2013 press release announcing the FDA clearance, Robert Munoz, vice president and general manager for Zimmer Extremities, said the primary challenges with reverse shoulder arthroplasty remain on the glenoid. "With PSI Shoulder, we present our surgeon customers with a powerful new tool to plan the glenoid side of the surgery with the patient's unique anatomy in full view and functional needs in mind, resulting in a physical reference in the operating room to complete the surgery with confidence."

"Zimmer's PSI Shoulder makes you look at the patient in an entirely different way, " said Dr. Olivier Verborgt, of AZ-Monica hospital, Antwerp Belgium, who has performed several Zimmer PSI Shoulder cases to date. "The planning software and patient-specific instrument guides help you think about what you want to do in the OR, and then actually do it."

3D Visualization

The 3D visualization software allows a surgeon to create a customized surgical plan for each patient, and then provide patient-specific surgical instruments guides to facilitate placement of the implant corresponding to the personalized surgical plan.

The system complements the company's Trabecular Metal Reverse Shoulder system for reverse shoulder arthroplasty (RSA) procedures.

Reverse Shoulder Arthroplasty

According to a PubMed, the RSA emerged as a potential solution for those patients who could not be managed effectively with a conventional total shoulder arthroplasty.

In 1987, Professor Paul Grammont revolutionized the design by medializing and distalizing the center of rotation and utilizing a large convex glenoid surface and concave humeral component with a neck-shaft angle of 155°. This design has been highly successful in cuff deficient shoulders, and indications continue to broaden. Many mid-term studies have improved upon the early encouraging results.

Exactech: Full Launch of Revision Systems and Expansion of Technologies

Elizabeth Hofheinz, M.P.H., M.Ed. • Fri, April 14th, 2017

Exactech, Inc., based in Gainesville, Florida, recently held the full market launch of the Optetrak Logic CC revision knee system; Alteon monobloc revision femoral stem; Equinoxe humeral reconstruction prosthesis; and the InterSpace tapered wedge hip spacer at the annual meeting of the American Academy of Orthopedic Surgeons (AAOS).

According to the March 14, 2017 news release, highlights of Exactech’s latest innovations include:

The Equinoxe Humeral Reconstruction Prosthesis offers a unique and stable solution for complex and challenging shoulder arthroplasty cases with significant humeral bone loss. Also featured was the new Preserve Stem, a conservative treatment option designed for preserving humeral bone.

The Optetrak Logic CC Revision Knee System offers a comprehensive portfolio to help surgeons address challenging revision cases. Exactech’s redesigned, intuitive instrumentation for an efficient, streamlined surgical experience will also be showcased.

The InterSpace Tapered Wedge Hip Spacer and data behind InterSpace’s preformed spacer technology with 20 years of clinical experience will be showcased. The AcuDriver Automated Osteotome Handpiece for implant removal was featured in live demonstrations.

Exactech CEO David Petty told OTW, “Exactech is pleased to now be in full launch mode with our latest innovations that address complex and challenging cases for surgeons and improved outcomes for patients. Our AAOS line-up included the full launch of three revision systems and expanded advanced surgical technologies.”

“For instance, the Equinoxe Humeral Reconstruction Prosthesis is the latest addition to our fast-growing Equinoxe shoulder system. The platform modular stem for hemiarthroplasty, anatomic total shoulder and reverse total shoulder applications allows us to support patients who have few options for reconstruction due to significant humeral bone loss. It integrates with the entire Equinoxe shoulder system, giving the surgeon intra-operative flexibility. (The Equinoxe Humeral Reconstruction Prosthesis is not indicated for use with the reverse shoulder components in oncology applications.)”

“The Optetrak Logic CC Revision Knee System includes a high-performance portfolio of implants, instruments and computer-assisted surgery for reproducible results in revision procedures.

Personalized Shoulder Reconstruction Implant From Zimmer Biomet

Walter Eisner • Tue, November 22nd, 2016

Zimmer Biomet Holdings, Inc. has introduced a personalized shoulder implant called the Comprehensive Vault Reconstruction System (VRS) for patients with a severely deficient rotator cuff and extensive bone loss which precludes the use of a standard glenoid baseplate.

Until now, treatment options for extensive glenoid deficiencies were limited to bone grafting or hemi-arthroplasty, said David Dines, M.D. an orthopedic surgeon at the Hospital for Special Surgery in New York. Dr. Dines is also a professor of orthopedic surgery at Weill Cornell Medical College. Dines said the previous treatment options were "unreliable and had marginal success."

In a November 17, 2016 company press announcement, Dines said the system "represents an important advance in shoulder reconstruction by streamlining and personalizing the implant procedure in hope of more predictable outcomes and results that extend beyond pain relief, to restoring function and improving overall quality of life."

Stephen Brockmeier, M.D., performed the first VRS implantation on September 21, 2016, at the University of Virginia Hospital in Charlottesville, Virginia.

The VRS was cleared by the FDA May 2016, just eight months after Biomet Manufacturing Corp. filed a 510k premarket notification of intent to market the system with the agency.

Indications

According to the FDA substantial equivalent determination, the system is indicated for use "in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

"The [system] is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

"Comprehensive Vault Reconstruction System glenoid baseplate components are intended for cementless application with the addition of screw fixation in patients with unusual anatomy and/or extensive bone loss which precludes the use of a standard glenoid baseplate component.

Medacta Anatomic and Reverse Shoulder Components Cleared

Walter Eisner • Tue, November 7th, 2017

Swiss family-owned Medacta International has received clearance from the FDA to market its Anatomic Shoulder and Reverse Shoulder components of its modular shoulder system in the U.S.

The company also announced on October 26, 2017 that the first surgery in the U.S. of the device was performed by Matthew Saltzman, M.D., associate professor of orthopaedic surgery at the Northwestern Memorial Hospital in Chicago, Illinois.

Saltzman said the procedure "went very well.” He added that the system’s instrumentation and implants allow for "impressive anatomic restoration, resulting in an efficient surgery and, hopefully, improved patient outcomes.”

The company says the system features a broad range of options, including wide-ranging sizes, adjustable offset, and innovative configurations developed by an international team of expert surgeons. The platform, states the company, "offers modularity and compatibility…while still respecting anatomic conversion from primary to reverse."

Predicates and Indications

The clearance notification for the reverse shoulder was filed in February 2017 and revised in early September. The primary predicate device was DePuy Orthopaedics Inc.'s Delta Xtend Reverse Shoulder System and Modular Stem.

The device is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement and a grossly rotator cuff deficient shoulder joint.

The anatomic shoulder notification was filed on July 17, 2017. The primary predicate device was Synthes' Epoca Shoulder Prosthesis System.

The device is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

The shoulder system was unveiled in February 2017 following its first ever surgery in Europe.